BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTREON¿

    MDR report key: 19367056 · Received May 21, 2024

    Report

    Report Number
    2024168-2024-06190
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 30, 2024
    Report Date
    September 3, 2024
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    NQQ
    PMA / PMN Number
    K150237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION, FUNCTIONAL TESTING ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED EVENT WAS CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. THE POWER TRAY WAS CONNECTED TO THE IN-HOUSE EQUIPMENT. WE NOTICED THAT THE POWER TRAY WAS HEATING UP, WHICH COULD BE FELT JUST AFTER FEW MINUTES OF POWERING UP, SPECIFICALLY THE TRANSFORMER SIDE. CONNECTED TEMPERATURE MONITOR. THE READING WENT FROM 77OF TO 140OF IN LESS THAN 5 MINUTES. BASED ON THE INFORMATION PROVIDED AND ANALYSIS OF THE RETURNED DEVICE, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. B5: DESCRIBE EVENT OR PROBLEM: UPDATED. D1: CORRECTION (BRAND NAME UPDATED). D2A: CORRECTION (COMMON DEVICE NAME UPDATED). D4: CORRECTED CATALOG NUMBER FROM 1014933 TO 600236033. D9, H3 - DEVICE RETURNING STATUS UPDATED FROM NI TO YES.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: FIELD SERVICE WAS PERFORMED AND INSPECTED THE SYSTEM LOOKING FOR ANY SIGN OF BURNT CABLES, ARC MARKS, & SYSTEM TEMPERATURE. AFTER BEING ON SITE FOR AN HOUR THERE WAS NO EXPERIENCE OF THE BURNING SMELL COMING FROM THE SYSTEM. A SECOND INSPECTION WAS PERFORMED AT A LATER DATE, THE PC AND THE POWER SUPPLY WERE OPENED TO SEE IF THERE ARC MARKS OR BURNT CABLES, WHICH THERE WERE NO EVIDENCE OF SUCH. FIELD SERVICE TECHNICIAN STAYED FOR AWHILE FOR THE ISSUE TO COME UP SINCE THE LAST TIME NOTHING WAS EXPERIENCED. AFTER THREE HOURS OF HAND TOUCH CHECKING THE SYSTEM, A SMELL OF MELT HEATING UP WAS NOTICED AND THE POWER MODULE WHERE THE COIL SITS WAS HEATING UP, THOUGH IT DID SMELL LIKE BURNING METAL FROM THE OUTLETS RIGHT ABOVE THE COIL AS WELL. THERE IS NO RESOLUTION AT THIS TIME OTHER THAN TO PROVIDE THE CUSTOMER WITH A NEW SYSTEM. FIELD SERVICE WAS PERFORMED AND THE POWER TRAY WAS REPLACED DUE TO SMELL OF OVERHEATED COMPONENT AND ISSUE WAS RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LAB SMELLED OF SMOKE AND IT WAS DETERMINED SMOKE WAS COMING FORM THE OPTICAL COHERENCE TOMOGRAPHY (OCT) CABINET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427385 ULTREON¿ SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) NQQ LIGHTLAB IMAGING, INC. 600236033 9218840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown